Country: United States
Language: English
Source: NLM (National Library of Medicine)
FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M)
Amneal Pharmaceuticals LLC
FLUOCINOLONE ACETONIDE
FLUOCINOLONE ACETONIDE 0.11 mg in 118.28 mL
TOPICAL
PRESCRIPTION DRUG
Fluocinolone Acetonide 0.01% Topical Oil is a low to medium potency corticosteroid indicated: In adult patients for the treatment of psoriasis of the scalp (Scalp Oil). Fluocinolone Acetonide 0.01% Topical Oil is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. This product contains refined peanut oil NF (see PRECAUTIONS section).
Fluocinolone Acetonide 0.01% Topical Oil is supplied in a 4 fluid ounce bottle with a net content of 118.28 mL. It is labeled as Scalp Oil (NDC 65162-703-86). Scalp Oil is supplied with 2 shower caps. Keep tightly closed. Store upright at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or www.amneal.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. CAUTION: Rx only Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807 Rev. 08-2015-00
Abbreviated New Drug Application
FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OIL AMNEAL PHARMACEUTICALS LLC ---------- FLUOCINOLONE ACETONIDE 0.01% TOPICAL OIL (SCALP OIL) For Topical Use Only- Not for Oral, Ophthalmic, or Intravaginal Use DESCRIPTION Fluocinolone Acetonide 0.01 % Topical Oil contains fluocinolone acetonide {(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4- diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid for topical use dermatologic use. This formulation is also marketed as Fluocinolone Acetonide 0.01% Topical Oil for use as body oil for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older, and as fluocinolone acetonide oil, 0.01% for chronic eczematous external otitis. Chemically, fluocinolone acetonide is C H F O . It has the following structural formula: Fluocinolone acetonide in Fluocinolone Acetonide 0.01% Topical Oil has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270ºC with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of Fluocinolone Acetonide 0.01% Topical Oil contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, and refined peanut oil NF. Each packaged product contains 2 shower caps. The shower cap is made of low density 24 30 2 6 polyethylene material with rubber elastic. CLINICAL PHARMACOLOGY Like other topical corticosteroids, fluocinolone acetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflamma Read the complete document